Prostate CancerPhase 2NCT00176527
Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase 2 study testing recombinant interferon alfa-2b, docetaxel and estramustine phosphate sodium in people with Prostate Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- recombinant interferon alfa-2b, docetaxel and estramustine phosphate sodium
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed hormone-refractory metastatic prostate cancer
- Patients who have been recently withdrawn from treatment with bicalutamide or flutamide must demonstrate progression of disease
- Measurable disease OR prostate-specific antigen level ≥ 10 ng/mL
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Estimated life expectancy ≥ 6 months
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 8 g/dL
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
- Bilirubin normal
- AST, ALT, and alkaline phosphatase (AP) must meet 1 of the following criteria:
- AP normal and AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- AP elevated and AST and ALT normal
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No peripheral neuropathy > grade 1
- No concurrent active infections
- No concurrent major depression or suicidal ideation
- No concurrent medical condition that would preclude study participation
- No known HIV positivity
- Fertile patients must use effective contraception during and for 10 weeks after completion of study therapy
PRIOR CONCURRENT THERAPY:
- Recovered from prior surgery or radiotherapy
- No prior chemotherapy, retinoids, or interferon therapy
- More than 4 weeks since prior flutamide
- More than 6 weeks since prior bicalutamide
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: A Phase II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and Estramustine (R.I.T.E.) for the Treatment of Hormone Refractory Prostate Cancer
RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate, in terms of change in measurable disease or prostate-specific antigen levels, in patients with hormone-refractory metastatic prostate cancer treated with isotretinoin, recombinant interferon alfa-2b, docetaxel, and estramustine phosphate sodium.
Secondary
- Determine the effect of this regimen on bcl-2 family proteins in peripheral blood mononuclear cell samples obtained from these patients.
OUTLINE: Patients receive oral isotretinoin once daily on days 1-4, recombinant interferon alfa-2b subcutaneously once daily on days 1-4, oral estramustine phosphate sodium three times daily on days 1-5, and docetaxel IV over 1 hour on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cells are acquired via blood draw at baseline and on days 2, 3, or 4 and analyzed for bcl-2 protein by IHC and electrophoresis.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- recombinant interferon alfa-2b, docetaxel, estramustine phosphate sodium, isotretinoin, polyacrylamide gel electrophoresis
- Keywords
- recurrent prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfa-2bBiological
docetaxelDrug
estramustine phosphate sodiumDrug
isotretinoinDrug
polyacrylamide gel electrophoresisGenetic
protein expression analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Response (biochemical and measurable disease)
Bcl-2 modulation in peripheral blood mononuclear cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: accrual goal met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert S. DiPaola, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176527
- Sponsor's protocol ID
- CDR0000540176
- Other IDs
- P30CA072720, CINJ#080107-3850
- Status last verified
- Dec 2009
- First submitted
- 12 Sep 2005
- Last updated
- 11 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and Estramustine (R.I.T.E.) for the Treatment of Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00176527
- Acronym / sponsor ID
- CDR0000540176
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: accrual goal met
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate, in terms of change in measurable disease or prostate-specific antigen levels, in patients with hormone-refractory metastatic prostate cancer treated with isotretinoin, recombinant interferon alfa-2b, docetaxel, and estramustine phosphate sodium.
Secondary
- Determine the effect of this regimen on bcl-2 family proteins in peripheral blood mononuclear cell samples obtained from these patients.
OUTLINE: Patients receive oral isotretinoin once daily on days 1-4, recombinant interferon alfa-2b subcutaneously once daily on days 1-4, oral estramustine phosphate sodium three times daily on days 1-5, and docetaxel IV over 1 hour on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cells are acquired via blood draw at baseline and on days 2, 3, or 4 and analyzed for bcl-2 protein by IHC and electrophoresis.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa-2b | Biological | – |
| docetaxel | Drug | – |
| estramustine phosphate sodium | Drug | – |
| isotretinoin | Drug | – |
| polyacrylamide gel electrophoresis | Genetic | – |
| protein expression analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
Primary outcome
Response (biochemical and measurable disease)
Bcl-2 modulation in peripheral blood mononuclear cells
Results and safety
The study was stopped early (reason given: accrual goal met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S. DiPaola, MD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alfa-2b, docetaxel and estramustine phosphate sodium in people with Prostate Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: accrual goal met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (biochemical and measurable disease). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.